Clinical research report on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions(2022)

Objective:The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials(RCTs)of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions published in 2022,to provide evidence and reasonable suggestions for the advancement of clinical research and the formulation of policies and guidelines.Methods:The Evidence Database System of clinical evidence-based evaluation of traditional Chinese medicine was searched,and data from China National Knowledge Infrastructure(CNKI),PubMed,and other databases were supplemented.The search duration was from January 1,2022,to December 31,2022.RCTs of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were included as the source of clinical evidence,and published information,sample size,intervention,control measures,treatment course,methodological quality,and key link report were analyzed and evaluated.Results:A total of 1,464 RCTs of traditional Chinese patent medicines were included,which comprised 667 types of traditional Chinese patent medicines;“traditional Chinese patent medicines+Western medicine vs.Western medicine”was the most widely used intervention and control setting,involving 417 RCTs(28.48%).A total of 245 RCTs of traditional Chinese classic famous prescriptions were included,comprising 55 types of traditional Chinese classic famous prescriptions.“Decoction+conventional treatment vs.conventional treatment”was the most widely used intervention and control setting,with 87 RCTs(35.51%).Published RCTs on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were limited by the study design and implementation.Most“allocation concealment”and“blinding of patients and personnel”were rated as medium to high risk.There are insufficient reports on key research links such as experimental registration and ethical approval.Conclusions:The number of RCTs on traditional Chinese patent medicines has decreased in 2022,but there has been a slight improvement in the research quality and impact.There are relatively few studies on traditional Chinese classic famous prescriptions.Measures must be taken to improve clinical trial design,implementation,and reporting.Methodological experts should be invited to provide professional technical guidance on the trial design.In the research implementation process,attention should be paid to quality control,particularly the standardization of the randomized execution.

Research on Technology Development of Traditional Chinese Medicine Extraction Based on Patent Information

Objective To understand the development status of traditional Chinese medicine extraction technology,so as to provide a reference for enterprises and scientific research institutions to determine the direction of technological innovation.Besides,the government can formulate scientific and technological innovation strategies.Methods Based on patent information,statistical methods were applied to analyze the development of traditional Chinese medicine extraction technology.Then,the core technology was identified by constructing a patent citation network.Finally,the main path analysis method was applied to discover the technological evolution path.Results and Conclusion The extraction technology of traditional Chinese medicine is still in the growth stage.At present,its R&D is based on enterprises,supplemented by scientific research institutions.The core technologies are ultrasonic extraction and enzymatic extraction.The main path represented by enzymatic extraction technology reveals the evolution process of traditional Chinese medicine extraction technology.Based on this,relevant suggestions are put forward.Firstly,technological innovation cooperation should be strengthened to explore new models of achievement transformation and cooperation.Secondly,key enterprises of technology clusters should be cultivated to accelerate breakthroughs in core technologies.Thirdly,combined technologies can achieve high-efficiency enzyme-assisted extraction and open up new ways of extracting traditional Chinese medicine.Fourthly,traditional techniques should be improved to develop innovative modern techniques.

Ultrasonic Nebulization Extraction Coupled with Gas Chromatography-Mass Spectrometry for Analysis of Volatile Components in Traditional Chinese Patent Medicine

The ultrasonic nebulization extraction（UNE） was developed and applied to the extraction of volatile components from traditional Chinese patent medicine Xiaoyao Pills. Several parameters of ultrasonic nebulization extraction including the sample particle size, solvent volume, extraction time and ultrasonic power were studied and selected. As a result, 2.4 g of sample with particle size of 80 mesh was extracted with 15 mL of n-hexane for 20 min at an ultrasonic power of 35 W. The volatile components were analyzed by gas chromatography-mass spectrometry （GC-MS） under the optimal conditions and 57 compounds were identified. The precision, repeatability and stability of the proposed method were also studied. Compared with ultrasonic-assisted extraction（UAE） and hydrodistillation（HD） extraction, the proposed method is more efficient, faster and easier to be operated at room temperature with smaller sample and energy consumption. It is suggested that the ultrasonic nebulization extraction can be used as a novel alternative method for the extraction of volatile components from traditional Chinese patent medicine.

Prescribing Chinese patent medicines without traditional Chinese medicine training is now banned in China

On July 1, 2019, the website of the National Health Commission of the People’s Republic of China issued the “Notice on printing and distributing the first batch of national key monitoring and rational drugs (chemicals and biological products)”(National Health Office Medical Letter [2019] No. 558)[1], where the third article stipulates:“Other types of physicians, after not less than one year of systematically studying Chinese medicine professional knowledge and passing the examination, in accordance with the basic principles of syndrome differentiation, can issue prescriptions for Chinese patent medicine”.

Based on the national patent database to explore the rule of traditional Chinese medicine in the treatment of hyperlipidemia

Objective:To explore the medication law of traditional Chinese medicine compound patent for hyperlipidemia,and to provide reference for the research and development of traditional Chinese medicine new drugs for clinical treatment of hyperlipidemia.Methods:All compound TCM patents related to the treatment of hyperlipidemia were searched and extracted from the national patent database(http://epub.sipo.gov.cn)from the establishment of the database to 10st,March 2021.The data was established by the TCM Inheritance Support System(V2.5)and Microsoft Excel 2010 Softwore,and used to conduct TCM syndromes,frequency statistics,four nature and five flavors of traditional Chinese medicine,meridian attribution statistics.IBM SPSS statistics 20 software was used for drug clustering analysis,IBM SPSS modeler 18.2.2 software was used for association rules and web visualization analysis.Results:Totally 284 compound TCM patents were included,involving 577 kinds of Chinese medicine,and the most common syndrome was Yin deficiency of liver and kidney syndrome(74 times,accounting for 26.06%).The most ten common Chinese materiamedica was Hawthorn,Salvia miltiorrhiza,Alismaorientalis,Cassia seed,Polygonummultiflorum,Licorice,Poriacocos,chinese rhubarb,dried tangerine peel,Radix Paeoniae Alba.The top three appeared frequently in drug categories were tonifying deficiency medicine,activating blood-circulation and dissipating blood-stasis medicine,and heat-clearing medicine,respectively.The top two of its drug properties were warm and cold;the top three drug tastes were sweet,bitterness and pungent;the top two meridians were liver and spleen meridian,respectively.Seven drug groups were obtained by cluster analysis,and 16 were obtained by association rule analysis,including 5 drug pairs and 11 three drug groups.Conclusion:Through the data mining of the patent of traditional Chinese medicine compound prescription for regulating and treating hyperlipidemia,it is concluded that the fundamental pathogenesis of the disease is deficiency of viscera function and obstruction of phlegm and blood stasis.The clinical methods are tonifying the liver and kidney,activating blood circulation and removing stasis,resolving phlegm and removing dampness.Traditional Chinese medicine is mostly used for tonifying deficiency,activating blood circulation,removing stasis,resolving phlegm and removing dampness.This paper provides a reference for the research and development of traditional Chinese medicine for hyperlipidemia.

Analysis of the rule of medication of compound Chinese traditional patent medicine for digestive system tumors based on data mining

Objective:Based on the data mining method,explore the medication rules of Chinese patent medicines for the treatment of digestive system tumors.Method:Based on the"Chinese Traditional Medicine Prescription Database"in https://db.yaozh.com/,collect Chinese patent medicines for the treatment of digestive system tumors,establish an Excel table,and use the ancient and modern medical case cloud platform(V2.2.1)to perform frequency statistics,association rules,and drugs on the data Clustering and complex network analysis.Results:A total of 36 Chinese patent medicines for the treatment of digestive system tumors were screened.The medicinal properties were mainly warm and cold,the taste was bitter and sweet,and the meridians were mainly liver and spleen meridians.High frequency Chinese medicine include Astragalus,Scutellaria-barbata,Ginseng,Curcuma,Triangle,Atractylodes,Hedyotis diffusa,etc.Correlation analysis obtained 17 drug combinations,High-frequency drug pairs include Scutellaria-barbata-Astragalus,Ginseng-Astragalus,Curcuma-Astragalus,Scutellaria-barbata-Curcuma,etc.Cluster analysis found 3 types of drugs.The core drug network is composed of 27 drugs,and the core compatibility network consists of 3 groups of drugs.Conclusion:The Chinese patent compound medicine for the treatment of digestive system tumors has the characteristics of combining cold and warming,replenishing and reducing treatment,and treating the liver and spleen at the same time.The medicine is mainly used to replenish qi and invigorate the spleen,promote blood circulation and remove blood stasis,and clear away heat and detoxification.Replenish qi,nourish yin,invigorate blood,and detoxify are mainly compatible with each other,reflecting the pathogenesis characteristics of"deficiency,stasis,and toxin"in digestive system tumors.Data mining can provide references for the prescription and compatibility of Chinese patent medicines.

Quality Control for Traditional Medicines–Chinese Patent Medicines

Ji Shen: Dr.Ma Shuangcheng,Director of Institutes for Control of Chinese Traditional Medicines and Ethnic Medicine,National Institutes for Food and Drug Control,is a long-term researcher on the quality standards of Chinese materia medica,Chairman Member of the Risk Assessment of the Pharmacopoeia of People's Republic of China ,and is also the Director Member of the Professional Committee of Drug Risk,China Pharmaceutical Association,and the Director Member of the Directors Committee of Chinese Materia Medica Quality and Safety.He has long been engaged in the control of the quality and safety of Chinese materia medica,and has also been included in the National 10000 Talent Plan.Let's invite Dr.Ma to give a report.Thank you.

Clinical practice guideline on traditional Chinese medicine in the treatment of influenza (2021)

Influenza is a serious public health problem that endangers the health of the global human population.Traditional Chinese medicine(TCM)is rich in theory and practical experience regarding the treatment of influenza,and TCM treatments have shown good curative effects,but there is a dearth of standardized clinical guidance.It is necessary to formulate a clinical practice guide based on evidence-based medicine.To this end,the Specialty Committee of Emergency,China Association of Chinese Medicine(Beijing,China)organized a team of clinical experts,methodological experts,and other multidisciplinary experts to develop a guideline with integrated research methods in the first place of TCM.This guide includes 23 recommendations.The prescription section contains 16 recommendations,including 5 recommendations for mild cases,5 recommendations for severe cases,3 recommendations for critical cases,and 4 recommendations for the recovery period;the portion covering proprietary Chinese medicines forms a total of 7 recommendations.This guide aims to provide the best evidence for clinicians and related practitioners to make decisions about influenza diagnosis and treatment in Chinese medicine.

Partial response to Chinese patent medicine Kangliu pill for adult glioblastoma: A case report and review of the literature

BACKGROUND Glioblastoma is the most common type of brain tumor and is invariably fatal,with a mean survival time of 8-15 mo for recently diagnosed tumors,and a 5-year survival rate of only 7.2%.The standard treatment for newly diagnosed glioblastoma includes surgery followed by concurrent chemoradiotherapy and further adjuvant temozolomide.However,the prognosis remains poor and longterm survival is rare.This report aimed to demonstrate a new therapeutic strategy for the treatment of glioblastoma.CASE SUMMARY A patient was referred to the Department of Neurosurgery with an intracranial space-occupying lesion with a maximum diameter of approximately 5 cm.The tumor was compressing functional areas,and the patient accordingly underwent partial resection and concurrent chemoradiotherapy.The imaging and pathological findings were consistent with a diagnosis of glioblastoma with oligodendroglioma differentiation(World Health Organization IV).The patient was finally diagnosed with glioblastoma.However,the patient discontinued treatment due to intolerable side effects,and was prescribed Kangliu pill(KLP)7.5 g three times/d,which he has continued to date.Significant shrinkage of the tumor(maximum diameter reduced from about 3.5 to about 2 cm)was found after 3 mo of KLP therapy,and the tumor was further reduced to about 1 cm after 3 years.The patient’s symptoms of headache,limb weakness,and left hemiplegia were relieved,with no side effects.CONCLUSION KLP has been a successful intervention for glioblastoma, and the current caseindicates that traditional Chinese medicine may offer effective alternativetherapies for glioblastoma.

Analysis and Suggestions on Patent Application Status for Traditional Chinese Medioine Cosmetics

From the perspective of patent application, the development process of traditional Chinese medicine （TCM） cos- metics was summarized. The legal status, regional distribution, applicants, and function distribution of patent applica- tions for TCM cosmetics in China were primarily analyzed. Suggestions on the future development of TCM cosmetics were given, and it was pointed out that it should pay more attention to intellectual property protection, as well as in- heriting TCM theory, only then TCM cosmetics can get an edge over the competition at home and abroad.

Appraising the quality of clinical practice guidelines in Chinese patent medicine

Background:Chinese patent medicine(CPM)is a type of traditional Chinese medicine(TCM)that utilizes Chi-nese medicinal materials as its raw ingredients.Following the principles of TCM theory,it undergoes specific processing techniques to create various dosage forms for the prevention and treatment of diseases.The current CPM guidelines,both domestically and internationally,are constrained by limitations in methodological quality and reporting,which do not adequately address the requirements of the majority of clinicians and patients.Objective:To evaluate the methodological rigor and reporting quality of clinical practice guidelines(CPGs)in CPM,with aim to assess their current quality and to provide recommendations for improving guideline develop-ment.Methods:The study utilized the Appraisal of Guidelines for Research and Evaluation II(AGREE II)tool and the Reporting Items for Practice Guidelines in Healthcare for Traditional Chinese Medicine(RIGHT for TCM)checklist to evaluate the methodological rigor and reporting quality of CPM guidelines.After the training session,the four investigators were divided into two groups to evaluate the guidelines of patent Chinese medicine included in this study based on the aforementioned criteria.In case of any discrepancies,a secondary analysis was conducted by all four researchers under the guidance of two clinical experts,ensuring an impartial evaluation outcome.Average score or average reporting rate were calculated for each domain.Results:A total of 32 CPM guidelines that met the inclusion criteria were analyzed.The AGREE II yielded an average score of 67.2%.The domain scores were as follows:scope and purpose(93.3%),stakeholder involve-ment(50.1%),rigor of development(76.8%),clarity of presentation(79.4%),applicability(40.1%),and editorial independence(63.6%).The average reporting rate of the RIGHT for TCM checklist was 70.0%,with the report-ing rates for the seven domains as follows:basic information(94.2%),background(87.9%),evidence(97.5%),recommendation(57.5%),review and quality assurance(11.4%),funding and declaration and management of interests(26.6%),and other information(68.8%).Conclusions:The methodological and reporting quality of CPGs for CPM have been deemed acceptable since 2020.However,there is still room for improvement,particularly in enhancing the reporting quality to provide clinicians and patients with more effective and comprehensive guidance.Additionally,it may be beneficial to develop a comprehensive reporting checklist specifically tailored for CPM guideline development.

Combination of western medicine and Chinese traditional patent medicine in treating a family case of COVID-19

In December 2019,an outbreak of novel coronavirus(2019-nCoV)occurred in Wuhan,Hubei Province,China.By February 14,2020,it has led to 66492 confirmed patients in China and high mortality up to^2.96%(1123/37914)in Wuhan.Here we report the first family case of coronavirus disease 2019(COVID-19)confirmed in Wuhan and treated using the combination of western medicine and Chinese traditional patent medicine Shuanghuanglian oral liquid(SHL).This report describes the identification,diagnosis,clinical course,and management of three cases from a family,suggests the expected therapeutic effects of SHL on COVID-19,and warrants further clinical trials.

Several Considerations in Using Traditional Chinese Patent Medicine for Cerebrallnfarction

Nowadays, a great number of traditional Chinese patent medicine （TCPM） are used more and more widely to treat cerebral infarction in China. When great attention is paid to using TCPM in the real world, several problems can be identified： ignoring the Chinese medicine （CM） therapeutic principle based on syndrome differentiation, a lack of appropriate dosage and usage based on individual patient conditions, and a shortage of evidence from randomized, double-blind, placebo-controlled clinical trials. Furthermore, in terms of evaluation of the TCPM effectiveness, few comprehensive criteria and evaluation methods recognized by the international community exist. This article addresses some opinions regarding the above mentioned problems.

A novel classification method for aid decision of traditional Chinese patent medicines for stroke treatment

Traditional Chinese patent medicines are widely used to treat stroke because it has good efficacy in the clinical environment. However, because of the lack of knowledge on traditional Chinese patent medicines, many Western physicians, who are accountable for the majority of clinical prescriptions for such medicine, are confused with the use of traditional Chinese patent medicines. Therefore, the aid-decision method is critical and necessary to help Western physicians rationally use traditional Chinese patent medicines. In this paper, Manifold Ranking is employed to develop the aid-decision model of traditional Chinese patent medicines for stroke treatment. First, 115 stroke patients from three hospitals are recruited in the cross-sectional survey. Simultaneously, traditional Chinese physicians determine the traditional Chinese patent medicines appropriate for each patient. Second, particular indicators are explored to characterize the population feature of traditional Chinese patent medicines for stroke treatment. Moreover, these particular indicators can be easily obtained by Western physicians and are feasible for widespread clinical application in the future. Third, the aid-decision model of traditional Chinese patent medicines for stroke treatment is constructed based on Manifold Ranking. Experimental results reveal that traditional Chinese patent medicines can be differentiated. Moreover, the proposed model can obtain high accuracy of aid decision.

A Systematic Review of RCTs and quasi-RCTs on Traditional Chinese Patent Medicines for Treatment of Chronic Hepatitis B

Traditional Chinese patent medicines (TCPMs) are widely used for treatment of chronic hepatitis B (CHB) in China. To estimate the overall effectiveness of TCPMs for CHB, we performed a systematic review of clinical reports designed as randomized controlled trials (RCTs). One hundred and thirty-eight available RCTs and quasi-RCTs on 62 TCPMs, involving 16,393 patients, were included. The methodological quality of these trials was generally "poor". Few trials (6.52%) reported the methods of randomization correctly. Another common problem was the lack of allocation concealment, proper blinding, and the reporting of lost cases and dropouts. Forty-two trials (30.43%) on 27 TCPMs reported some anti-viral effect of TCPMs. Others reported beneficial aspects, including improvements of liver function (79.71% of the studies), liver fibrosis (29.99%), and CHB symptoms (92.75%). Forty-one articles (29.71%) reported mild adverse events with TCPMs but these occurred infrequently. In summary, the outcome of the report on currently registered TCPMs may be biased due to poor methodology. The data from these trials, therefore, is too weak to use in forming a recommendation for treatment of CHB. Nevertheless, five drugs (Dan Shen agents, Da Huang Zhe Chong pill/capsule, Shuang Hu Qing Gan granule, Fu Zheng Hua Yu granule and Cao Xian Yi Gan capsule) appear to be more effective than the other TCPMs.

Value and influencing factors of valid Traditional Chinese Medicine compound prescription patents for mammary gland hyperplasia

OBJECTIVE: To explore the value and factors influencing the maintenance of valid Traditional Chinese Medicine compound prescription patents for the management of mammary gland hyperplasia. METHODS: The State Intellectual Property Office Patents Database, China Patent Information Center Patents Database, Soopat Patent Search Platform, and CNIPR Search Platform of Chinese and Foreign Patent Database were searched to identify Traditional Chinese Medicine compound prescription patents for mammary gland hyperplasia that had been maintained for at least 5 years. Logistic regression analysis was used to detect the factors influencing the maintenance of valid patents. RESULTS: From 1 January 1993 to 31 December 2019, a total of 1228, Traditional Chinese Medicine compound prescription patents for mammary gland hyperplasia were authorized. Of these applications, 381 patents were granted and only 176 patents were maintained for more than 5 years. The five independent variables assessed in this study all had significant explanatory functions. CONCLUSIONS: The maintenance of valid patents for Traditional Chinese Medicine compound prescriptions for treating mammary gland hyperplasia is of great importance. The maintenance of such patents depends on many factors, such as the concentration of effective herbs, number of dependent claims, provision of new dosage forms and detailed experimental data, and transfer of patent rights.

Research on Medication Regularity of Traditional Chinese Medicine Based on Hyperuricemia Patents

Objective To study the medication regularity of Chinese herbal medicines based on hyperuricemia patents. Methods Access database was established to summarzie the patents regarding hyperuricemia disclosured by State Intellectual Property Office（SIPO） of the People＇s Republic of China in 1986-2015. Statistically analysis was performed by Chinese Medicine Inheritance Support System（TCMISS）. Results The literatures of Chinese herbal medicines treating hyperuricemia were 1223, and 138 papers were included by excluding and screening, and contain 282 kinds of traditional Chinese medicine. Conclusion By analyzing the frequency, efficacy, flavor, channel tropism,and composition of the herbs used, we recognize that the efficacy of herbs in curing hyperuricemia is mostly clearing heat and promoting diuresis, invigorating the circulation of blood, dispersing stasis, alleviating water retention, and reinforcing deficiency concurrently. Flavors are mostly sweet, bitter, and cold. Channel tropism is mainly to liver, spleen, stomach, lung, and kidney. It provides the medication consideration for clinical treatment of hyperuricemia.

Progress of Traditional Chinese Medicine Treating COVID-19

The new coronavirus pneumonia(coronavirus disease 2019[COVID-19]),caused by the new coronavirus(severe acute respiratory syndrome coronavirus 2[SARS-CoV-2]),mainly manifests by fever,dry cough,and fatigue.The emergence of SARS-CoV-2 poses a huge threat to people’s lives.Unfortunately,so far,there are no effective treatment drugs and vaccines.Traditional Chinese medicine(TCM)has played an important role and achieved good results for treating this epidemic.More than 85%of patients with SARS-CoV-2 infection in China have received TCM treatment.In this article,we describe the progress of TCM for the COVID-19 therapy.

日本汉方药物的妊娠期和哺乳期风险评估及对我国中成药的影响

目的:通过对日本汉方药物的药品说明书进行妊娠期和哺乳期风险分析,评估日本汉方药物的用药风险及其对于我国中成药妊娠期风险评估的影响,为进一步开展我国中成药的妊娠期和哺乳期风险评估提供借鉴及参考。方法:针对日本医药品与医疗器械局平台收集及整理的148种医用日本汉方药物相关药品说明书,分析妊娠期和哺乳期相关表述,评估具有用药风险的日本汉方药物及中药组分。结合我国《中华人民共和国药典:一部》(2020年版)、《中药药物警戒》和《中药药性论》等中药典籍,对日本汉方药物可能存在的妊娠期潜在风险进行评估。基于日本汉方药物妊娠期风险中药组分,对我国505种中成药进行妊娠期风险评估,分析其对我国中成药妊娠期风险的影响。结果:日本148种日本汉方药物中,存在妊娠风险的药物共39种。妊娠期风险的中药组分包括大黄、牡丹皮、附子、桃仁、牛膝、芒硝和红花,主要为自身毒性及对于流产、早产的影响。哺乳期风险日本汉方药物中,因含有大黄而易引起新生儿腹泻的药物共18种。根据我国典籍评估,日本汉方药物具有潜在风险共93种。依据日本汉方药物风险组分,我国505种中成药中具有妊娠期潜在风险的药物共59种,占345种未标注妊娠期禁忌药物种类的17.1%。结论:日本汉方药物基于妊娠期和哺乳期风险的中药组分对其日本汉方药物成药风险进行评估,其特殊人群的风险表述方法对我国中成药发展具有一定的借鉴意义。